X-RepairSL Z021-80SL

GUDID B05502180

X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 80mm (WxL)

SYNTHASOME, INC.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: B05502180
• NIH Device Record Key: 65e9f552-8a0d-4a46-8a12-21d09a05bc81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-RepairSL
• Version Model Number: Z021-80SL
• Catalog Number: Z021-80SL
• Company DUNS: 140697280
• Company Name: SYNTHASOME, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com
• Phone: 858-490-9400
• Email: info@synthasome.com

Device Dimensions

• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter
• Width: 6 Millimeter
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B05502180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141499

FDA Product Code

• OWW: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [X-RepairSL]

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• B05502280SL: X-RepairSL, Bioabsorbable surgical mesh, single layer, 12mm x 80mm (WxL)
• B055021160SL: X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 160mm (WxL)
• B055020160SL: X‐RepairSL, Bioabsorbable surgical mesh, single‐layer 4mm x 160mm (WxL)
• B05502180: X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 80mm (WxL)
• B05502120: X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 20mm (WxL)
• B05502080: X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 80mm (WxL)
• B05502020: X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 20mm (WxL)